EP0119357B1 - Suture rings for heart valves - Google Patents

Suture rings for heart valves Download PDF

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Publication number
EP0119357B1
EP0119357B1 EP83307756A EP83307756A EP0119357B1 EP 0119357 B1 EP0119357 B1 EP 0119357B1 EP 83307756 A EP83307756 A EP 83307756A EP 83307756 A EP83307756 A EP 83307756A EP 0119357 B1 EP0119357 B1 EP 0119357B1
Authority
EP
European Patent Office
Prior art keywords
ring
retainer ring
protrusion
deformable
band
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
EP83307756A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0119357A1 (en
Inventor
Jerome John Klawitter
Harry Webb Cromie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Hemex Inc
Baxter Travenol Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hemex Inc, Baxter Travenol Laboratories Inc filed Critical Hemex Inc
Priority to AT83307756T priority Critical patent/ATE27542T1/de
Publication of EP0119357A1 publication Critical patent/EP0119357A1/en
Application granted granted Critical
Publication of EP0119357B1 publication Critical patent/EP0119357B1/en
Expired legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue

Definitions

  • the present invention relates to heart valve prostheses and more particularly to improved suture rings for implanting heart valves.
  • Heart valves having pivoting valve members either in the form of a single occluder, such as described in US ⁇ A ⁇ 4,123,805, or a pair of leaflets, such as described in US ⁇ A ⁇ 4,254,508, provide good flow characteristics and quick response to blood flow.
  • they commonly have attached fabric members suturable to the tissues of the heart.
  • the fabric member is attached to a separate suture ring which is applied to the periphery of the heart valve body or orifice ring, for example, as described in US ⁇ A ⁇ 3,763,548.
  • deformability of the heart valve body is advantageous as where the occluder and valve body have cooperating depressions and protrusions and the resiliently deformable valve body is deformed to permit insertion of the occluder and the resilient valve body is allowed to spring back into engagement with the occluder.
  • engagement of the occluder with the valve body may be accomplished by deformation of the occluder or by other means.
  • deformability of the valve body is undesirable in an assembled heart valve. Although after insertion into the heart, the valve is not subjected to substantial deforming forces, the possibility remains that a surgeon could inadvertently deform the orifice ring and dislocate the occluder as he is inserting the valve into the heart.
  • the heart valve body in combination with the suture ring should therefore provide sufficient resistance to deformation that there is no danger of displacing the occluder during insertion into the heart.
  • suture rings which together with the heart valve bodies occupy a narrow region along the heart passageway and which together provide the rigidity needed to assure that the valve body will not be deformed during insertion.
  • the fabric member portion of the suture ring should be continuous, fully covering any exposed metal portions of a suture ring, and exposed seams and fabric ends are to be avoided.
  • US-A-3 691 567 describes a heart valve with a suture ring of the type with which the invention is concerned.
  • the invention relates to a combination of heart valve and a suture ring for securing the heart valve to the tissues of the heart; said heart valve having a valve body providing a blood flow passageway, occluder means mounted within said valve body for opening and closing the passageway and a protrusion around the valve body having first and second surfaces, said suture ring comprising a retainer ring having an interior surface proportioned to surround said protrusion, inwardly extending means for locating with said first surface of the protrusion and a deformable ring portion for locating with the second surface of the protrusion to lock said retainer ring onto the protrusion, a fabric tube and band means for securing the ends of said fabric tube to said retainer ring so that exposed surfaces of said retainer ring when it is locked onto said protrusion are fully covered by said fabric tube.
  • a general object of the present invention is to provide an improved assembly of this type.
  • the band means is a first band for securing one end of said fabric tube to said retainer ring and a second band for securing the other end of said fabric tube to said retainer ring.
  • the retainer ring has deformable means which is deformed to hold at least said first band in permanent position.
  • the retainer ring has a tine means substantially encircling said first and second bands.
  • the protrusion on which the retainer ring is locked is preferably an outwardly extending portion of a stiffener ring received in interference fit in a peripheral groove in the valve body.
  • FIGURE 1 Illustrated in FIGURE 1 is a heart valve 11 which carries a suture ring assembly 13 particularly adapted for insertion in a mitral location.
  • the suture ring assembly has an outer covering 15 of porous fabric which can be sutured to the tissue of the heart and to which the fibrous tissues of the heart will attach during healing.
  • the illustrated heart valve 11 has a pair of generally semi-circular leaflets 17 mounted within an orifice ring or valve body 19 for pivoting between an open position to allow blood flow through the orifice or passageway and a closed position to block blood flow.
  • the leaflets 17 are mounted in the orifice ring by suitable interengagement means (not shown) which may include depressions and/or protuberances on the interior of the orifice ring and cooperating depressions and/or protuberances at the periphery of each leaflet, which interengagement means forms no part of the present invention.
  • Such orifice rings are often formed of materials that are somewhat resiliently deformable in order to be deformed for insertion of the valve members 17.
  • the orifice ring 19 returns to its annular configuration, the depressions and/or protrusions of the orifice ring and valve members 17 mount the valve members for pivotal motion.
  • a particularly suitable material for formation of valve members and orifice rings is pyrocarbon, such as that sold under the name PYROLITE, which has a surface with highly thromboresistant characteristics.
  • Orifice rings formed of pyrocarbon or of materials such as graphite coated with pyrocarbon may be deformed sufficiently for mounting of the valve members.
  • Heart valves 11 generally have orifice rings 19 with shallow outwardly facing annular grooves 23.
  • the suture ring assembly 13 includes an inner stiffener ring 25, which interfits with the annular groove and stiffens the orifice ring against deformation during surgical implantation, an outer surrounding retainer ring 33 and a fabric member 31 which is suturable to the tissues of the heart.
  • An inner surface 27 of the stiffener ring 25 is held in interference fit within the shallow annular groove 23, and the thickness of the ring is such that its outer surface 29 extends radially outward of the outer surface of the orifice ring.
  • the retainer ring 33 has an interior region or groove 34 which accommodates the outwardly protruding portion 28 of the stiffener ring 25 with the fabric member 31 interposed and held therebetween.
  • the fabric member 31 which is initially tubular in shape, is wrapped into a closed loop configuration around the retainer ring 33 with its ends 35a, 35b joined together to form the cover 15 which fully surrounds the retainer ring, and the junction between the overlapping ends 35 of the tubular fabric member is locked into a non- exposed position. Enclosure of the junction is achieved by a deformable section comprised of a ring of tines 41 that extend from a rigid annulus 43 of the retainer ring and are crimped into a curved configuration around the junction.
  • the application of the suture ring assembly 13 to the heart valve is as follows.
  • the stiffener ring 25, which is formed of metal, is shrink-fitted into an interference fit within the outwardly facing groove 23 by first heating it to expand its diameter.
  • the fabric member 31 is wrapped into its closed loop configuration around the retainer ring 33 and its ends are joined with a pair of cords or ties, one tie 37a banded around a first end 35a and a second tie 37b banded around the second end 35b.
  • the ring of tines 41 which have been partially precrimped outward (as shown in FIGURE 3), are further crimped toward the annulus 43 to lock in the ties and surrounding fabric.
  • the fabric-covered retainer ring 33 is thereafter snapped into the stiffener ring 25 by means of a deformable segment consisting of a ring of resilient prongs or tangs 45 that extend from the annulus 43 in the opposite direction from the tines 41.
  • suture ring assembly will now be described in greater detail. Although it is understood that the heart valve and suture ring assembly will be oriented within the heart valve in the orientation of the replaced natural heart valve, for ease of explanation, the vertical orientation of the several members will be described with reference to FIGURES 1-5 of the drawings.
  • the stiffener ring 25 is of annular shape having a generally rectangular cross section; however, the upper outer edge 47 is chamfered to facilitate application of the retainer ring 33 as described hereinbelow.
  • the inner surface 27 of the stiffener ring is generally matched to the shape of the shallow groove 23 of the orifice ring 19 with the inside diameter of the stiffener ring substantially equal to the root diameter of the groove and the height of the stiffener ring substantially equal to that of the groove.
  • the thickness of the stiffener ring is greater than the depth of the groove so that the outer surface 28 of the ring protrudes radially outward of the orifice ring 19.
  • the stiffener ring 25 As a means of fitting the stiffener ring 25 over one end of the orifice ring 19 and into the groove 23, the stiffener ring is first heated to high temperatures until it expands sufficiently to slide over the ring.
  • the heat-expanded stiffener ring is positioned around the groove and cooled to ambient temperatures whereat it seats snugly in the groove.
  • the metal of which the stiffener ring is formed has a coefficient of thermal expansion sufficient to permit its application, when heated, to the orifice ring.
  • the stiffener ring in the final assembly is shielded by the fabric covering 15 from contact with blood or tissue, the metal used to form the stiffener ring is selected for biocompatibility and thromboresistance.
  • a Co-Cr alloy is a preferred material for formation of the stiffener ring which may be heated to about 900°F for application to the orifice ring.
  • the retainer ring 33 is fabricated as a unitary, generally tubular piece of metal appropriately slit to provide the rings of tines 41 and tangs 45 extending in opposite directions from the central annulus 43.
  • the retainer ring is fully covered with fabric in the complete heart valve-stiffener ring-retainer ring assembly, the metal is also selected for biocompatibility and thromboresistance.
  • the central portion of the metal retainer ring has a thickness sufficient that it will not deform under the conditions of suture ring assembly.
  • the tangs 45 are less thick and in the process of suture ring assembly will deflect, but the "memory" of the resilient metal returns the tangs to their original configuration.
  • the tines 41 are relatively thin and are deformed past their elastic limit and during suture ring assembly assume the shape into which they are deformed.
  • a preferred metal for fabrication of the retainer ring is titanium.
  • Other metals, such as stainless steel, may also be used to fabricate the retainer ring, or a material having similar deformable properties might be used instead of metal.
  • the central annulus 43 is relatively thick giving shape and rigidity to the retainer ring 33.
  • the inner surface 51 of the annulus has a diameter slightly greater than the outer diameter of the orifice ring to accommodate a layer of fabric therebetween.
  • the inwardly facing annular groove or region 34 is formed to accommodate the outwardly protruding portion 28 of the stiffener ring 25 leaving a lower annular rim 44.
  • the groove 34 is proportioned to accommodate a single layer of the tubular fabric member 31 interposed between the stiffener ring and the retainer ring along an upper surface or overhang 57, a vertical surface 59 and a lower surface 65 of the groove.
  • the retainer ring 33 is divided by a plurality of slits 55 into the ring of resilient tangs 45 extending downward from the central annulus 43:
  • the lower rim 44 is divided by the slits 55 into radially inwardly extending lugs 61 at the ends of the tangs 45.
  • the undersurfaces 63 of the lugs 61 are rounded to facilitate camming of the lugs over the upper surface 64 and the outer surface 29 of the stiffener ring 25 during mating of the retainer ring to the orifice ring-stiffener ring assembly.
  • the thickness of the tangs 45 is such to allow them to deform outwardly during retainer ring application and snap back thereafter to surround and engage the stiffener ring.
  • a thin tubular portion 67 of the retainer ring 33 is divided by a plurality of slits 68 into the ring of tines 41.
  • the thin tines are deformed past their elastic limit upon the application of sufficient crimping force thereto.
  • the tines 41 are precrimped prior to application of the fabric member, using suitable dies, into the outwardly curved configuration seen in FIGURE 3, and the precrimped tines, along with an outwardly extending flange 71 of the annulus 43, provide an outwardly facing annular region 79.
  • the fabric member 31 is formed of fabric selected for lifetime durability as well as compatibility with blood and heart tissue.
  • a woven or knitted fabric provides porosity for ingrowth of heart tissue, and a preferred material for the fabric member is Dacron knit fabric.
  • the length of the tubular fabric member is sufficient to fully surround the retainer ring closely following its contours as well as providing a radially extending flap 75 for suturing to the heart tissue.
  • the flap 75 be thickened, and this is preferably accomplished by means of a resilient polymeric filler ring 76, e.g., formed of low density or foam polytetrafluoroethylene, such as that sold under the trademark Teflon.
  • the filler ring has a semi-elliptical cross section, its inner surface 78 being substantially vertical and having a diameter matched to the outside diameter of the finally crimped tines 41 as seen in FIGURE 5.
  • Teflon filler ring 76 is easily penetrated by suturing needles.
  • the flap could be thickened using a longer fabric member 31 and folding and layering its ends, but the close knit of the fabric makes it difficult for suturing needles to penetrate multiple layers.
  • the tubular fabric member 31 is wrapped around the retainer ring 33 prior to its application to the orifice ring 19 and fitted stiffener ring 25.
  • the fabric member 31 is shown in FIGURE 2 in its simple tubular configuration; however, prior to application to the retainer ring, the fabric member is preferably pre-creased, e.g., by steam pressing, in order to closely conform to the shape of the retainer ring which it is to cover.
  • Various dies are used in pre-creasing the fabric member to conform to the contours of the retainer ring.
  • the fabric is creased to follow the contours of inwardly facing annular region 34. On the outside of the retainer ring, a segment of the fabric stretches from the undersurface 63 of the lugs to the upper surface of the central portion of the retainer ring 33.
  • the first or lower end 35a of the fabric member is securely tied with one of the suture cords 37a leaving a short length 81 of the first end extending beyond the point of tying.
  • the outwardly curved tines prevent upward displacement of the tightly tied cord.
  • the filler ring 76 is then placed around the ring of precrimped tines 41, its inner surface 78 being deformed by the tines which have not yet been fully crimped, as seen in FIG. 3.
  • the second or upper end of the fabric member 31 is brought around the filler ring 76, tucked below the tines 41 and tied tightly with the second cord 37b within the annular region 79.
  • the second end overlaps the first end completing the closing loop configuration of the fabric covering 15.
  • the free terminus 83 of the second end extending beyond the tie is folded back upon itself into the region radially exterior of the two ties so it lies along the free length 81 of the first end leaving no exposed fabric ends to fray or interfere with the flow of blood.
  • the second cord may be knotted, its ends may be threaded through the fabric and tied exterior of the closed fabric loop.
  • the cords maintain the fabric in position along the retainer ring and filler ring 76.
  • the tines 41 are then crimped to their final configuration so they extend substantially back to the flange 71 of the annulus 43, locking the cords 37 and fabric end portions in the annular region 79 between the crimped tines and the flange.
  • the loose multilayered flap 75 of the fabric member is steam-pressed for the final time into a flat annular configuration extending radially outward of the upper end of the retainer ring for suturing to the heart tissues and in particular to the tissue at the interior of a passageway remaining after excision of a natural mitral valve.
  • the fabric-covered suture ring at this stage may be coated with vapor-deposited carbon, such as that sold under the name Biolite, giving the exposed fabric a highly thromboresistant surface.
  • the covered, coated retainer ring is ready for application to the heart valve-stiffener ring assembly.
  • the retainer ring is pressed downward over the orifice ring-stiffener ring assembly as seen in FIGURE 4.
  • the tangs 45 resiliently deform outwardly, and when the flat upper surfaces 65 of the lugs reach the bottom edge of the stiffener ring, the tangs spring back inward locking the retainer ring in surrounding relationship about the stiffener ring.
  • the retainer ring With the horizontal upper surface 57 of the groove 34 located along the horizontal upper surface 64 of the stiffener ring 25 and the horizontal lower surface 65 of the groove located along the horizontal lower surface 66 of the stiffener ring, the retainer ring is securely locked to the stiffener ring.
  • the retainer ring With the inwardly facing annular region 34 of the retainer ring thus engaged about the outer surface 28 of the stiffener ring, the retainer ring is secured to the orifice ring with the fabric member interposed and firmly held between the retainer ring and the stiffened orifice ring.
  • any slack in the inner portion of the fabric member is taken up so the fabric, which surrounds the retainer ring, now fully covers the surfaces of the protruding portion of the stiffener ring.
  • FIGURE 6 Illustrated in FIGURE 6 is an alternative embodiment of a heart valve 111 and a surrounding a suture ring 113 particularly adapted for insertion in an aortic location.
  • the heart valve 111 and suture ring 113 will in use be orientated in accordance with anatomy of the heart, for ease of description, the heart valve and suture ring are described as having an upper and a lower end, with reference to FIGURES 6-10.
  • the illustrated heart valve 111 has a single disc occluder 115 mounted within an orifice ring or valve body 117 for pivoting between an open position to allow blood flow through a central passageway 119 and a closed position to block blood flow through the passageway.
  • the valve body 117 is stiffened by being formed with an integral encircling protrusion 121. Because of the stiffness provided by the integral protrusion, it may be desirable to form the occluder 115 to be sufficiently resiliently deformable to permit its insertion into the valve body 117, or the occluder and/or mounting means may be fabricated to permit mounting of the occluder in a substantially non-deformable valve body. It is to be understood that the aortic suture ring 113 is equally suitable for use with a heart valve such as that illustrated with reference to FIGURES 1-5, having a stiffener ring in interference fit in a peripheral groove of the heart valve body.
  • Physiological differences between the mitral and aortic locations require some design differences between suture rings used in mitral locations and suture rings in aortic locations.
  • the mitral valves extend between two heart chambers, and when a defective natural mitral valve is removed, a broad surface is provided along the entrance to the opening.
  • a broad suture flange such as that in the embodiment of FIGURES 1-5, is preferably attached thereto.
  • the suture ring In the aortic location, however, the suture ring must be sutured to the walls of the passageway, and such a broad suturing flange is not appropriate for an aortic valve suturing ring.
  • a fabric tube 123 in the aortic ring fully covers the surfaces of a retainer ring 125
  • the fabric tube 123 is preferably not interposed between the valve body protrusion 121 and the retainer ring in order to further minimize the thickness of the valve body-suture ring assembly, but rather, the fabric tube is secured between the valve body 117 and retainer ring 125 at locations both above and below protrusion 121.
  • the retainer ring 125 is fabricated as a unitary, generally tubular piece of metal.
  • the main body is a narrow central annulus 127 having an interior surface 129 proportioned to fit closely about the outer surface 131 of the encircling protrusion 121 and an annular flange 135, that extends inward of the annulus 127 and lies adjacent the upper surface 137 of the protrusion 121.
  • a thin tubular section 139 extends a substantial distance upward from the body and is deformed inward in the assembled unit. Because it is not intended to greatly deform this section, there should be no need to provide slots to accommodate deformation without buckling, and in the illustrated embodiment, none are provided.
  • a lower thin tubular section or portion 141 extends a substantial distance downward from the main body, and because this tubular section is deformed substantially during its application to the valve body, a plurality of slots 143 (FIGURE 7) are formed extending upward into this lower tubular section creating a plurality of individually deformable tangs 145.
  • the lower end of the tubular portion 141 is formed with a rib that extends inward to provide each tang with an inward protuberance 147.
  • the tangs 145 in the aortic suture ring resemble the tangs in the herein before-described mitral suture ring, each having an inward protuberance, the tangs of the aortic suture ring are crimped into engagement about the valve body protrusion 121, rather than being snap-fit onto the protrusion, as is the case in the mitral valve suture ring.
  • the protuberance 147 do not extend sufficiently inward to lie below the protrusion until they are irreversibly deformed by crimping.
  • the narrow, horizontal upper surfaces 149 of the tang protuberances 147 provide secure locking when the tangs are crimped to lock the retainer ring 125 to the valve body.
  • the interior surface 129 of the main body does not extend the full distance along the valve body protrusion 121 permitting the tangs 145 to be formed of greater length and therefor more easily crimped.
  • the length of the fabric tube is preferably substantially longer than the height of the retainer ring to provide a double layer of material along the exterior of the retainer ring to be sutured to the heart tissues and to also provide portions that envelop the upper and lower ends and are tucked between the retainer ring and the valve body and held therein by means of dam rings or bands 151, 153.
  • the fabric tube is preferably precreased for fitting around the ends of the retainer ring and looping around upper and lower fabric-holding bands 151, 153.
  • the fabric-holding bands 151, 153 secure the ends of the fabric tube to the retainer ring to fully cover those portions of the retainer ring that would otherwise remain exposed after the retainer ring is locked to the valve body, and they are formed of rigid metal. Rigid metal bands are preferable to tied cords for securing fabric ends between two generally rigid members, i.e., the valve body 117 and the retainer ring 125, and facilitate assembly.
  • the illustrated bands 151, 153 have rectangular cross sections being cut from cylindrical tubes; however, bands having round cross sections or other configurations could be used.
  • the bands typically have cross-sectional dimensions of about 0.7 mm in the axial direction by 0.5 mm in the radial direction for a rigid metal, such as titanium.
  • the upper band 151 is proportioned for insertion between the upper tubular segment 139 of the retainer ring 125 and the heart valve body 117 above the protrusion 121 leaving sufficient clearance around the band for a looped portion of the fabric tube 123 to surround the ring.
  • the outside diameter of the upper ring is closely matched to the interior diameter of the upper tubular segment 139 whereby the fabric is captured between the band 151 and the tubular segment, and a slight amount of inward crimping of the upper . tubular segment is sufficient to retain the upper band 151 in its installed position on the retainer ring.
  • Insertion of the fabric-surrounded upper band 151 and inward crimping of the upper tubular segment 139 is generally completed before the retainer ring is applied to the valve body, the upper tubular segment serving no function in locking the retainer ring 125 to the valve body.
  • the lower band 153 is proportioned to be received between the tangs 145 and the valve body 117 as shown in FIGURE 9, where it can be seen that the outside diameter of the lower band 153 is significantly less than the uncrimped interior diameter of the ring of tangs 145.
  • the tangs are crimped a substantial distance inward serving the dual functions of pinning the lower end of the fabric tube between the band 153 and the lower surface 155 of the protrusion 121 and holding the lower band 153 in permanent position between the retainer ring and the protrusion to lock the retainer ring to the valve body.
  • the retainer ring 125 is placed on a jig (not shown), and the fabric tube 123 is extended through the central passageway of the retainer ring with that portion of the fabric tube which is to serve as an inner fabric layer 152 at the upper end.
  • the upper band 151 is then inserted into retainer ring along the inside of the upper tubular segment 139 and inside of the fabric tube 123 and pushed downward to hold the fabric tube against the inwardly extending flange 135.
  • a die is used to crimp the upper tubular segment 139 radially inward until its upper edge overhangs the upper band 151, locking the upper band in place and firmly pinning the fabric tube between the upper band and the upper tubular segment 139 and flange 135.
  • the upper portion 152 of the fabric tube 123 above the ring is folded over the upper edge of the upper tubular segment 139 and downward along the outside of the retainer ring, extending almost to its lower end.
  • the remaining portion 154 of the fabric tube 123 is pulled up through the central passageway of the retainer ring and likewise folded over the top and along the outside of the retainer ring overlying the inner layer 152 of the fabric tube.
  • the partially prepared suture ring (FIGURE 8) is ready for application to a heart valve body 117 having a surrounding protrusion 121, and the retainer ring 125 is removed from the jig.
  • valve body 117 and partially prepared retainer ring 125 are then mated (as shown in FIGURE 8).
  • the retainer ring 125 is inverted and inserted into another jig (not shown).
  • the valve body 117 is inserted into the retainer ring 125 so that the body protrusion 121 seats on the suture ring flange 135 with the outer surface of the protrusion 131 fitting closely along the interior surface 129 of the central annulus 127.
  • That portion of the fabric tube 123 that extends below the tangs is folded inward, and the lower band 153 is pushed downward into the annular region between the inverted valve body 117 and the tangs 143 until it seats against the protrusion 121, carrying the surrounding fabric inward so that a loop 159 of fabric is pinned between the band and the valve body 117.
  • the tangs 145 are crimped inward to lock the suture ring to the valve body by pressing them against the lower band 153 and the fabric tube loop 159 to force them against protrusion. Any excess fabric tube that extends outward beyond the end of the valve body and retainer ring is trimmed away.
  • the fabric may also be coated with vapor-deposited carbon.
  • the suture rings are fully assembled with the heart valves prior to their insertion into a heart where they are implanted by suturing.
  • the protrusions whether they are integral with the valve bodies or are separate stiffener rings, provide rigidity to otherwise thin, somewhat flexible, valve bodies eliminating the possibility that the valve members may be released from the valve bodies during surgical implantation into the heart.
  • the outer fabric coverings have no exposed seams, through which blood might seep or which might be pulled loose, nor any exposed ends.
  • the simple assembly of the retainer rings and the convenient means for locking the retainer rings onto the valve bodies substantially reduce the assembly time, which represents a significant portion of present heart valve manufacturing costs.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • External Artificial Organs (AREA)
EP83307756A 1983-01-17 1983-12-20 Suture rings for heart valves Expired EP0119357B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT83307756T ATE27542T1 (de) 1983-01-17 1983-12-20 Nahtringe fuer herzventile.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/458,618 US4535483A (en) 1983-01-17 1983-01-17 Suture rings for heart valves
US458618 1983-01-17

Publications (2)

Publication Number Publication Date
EP0119357A1 EP0119357A1 (en) 1984-09-26
EP0119357B1 true EP0119357B1 (en) 1987-06-03

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP83307756A Expired EP0119357B1 (en) 1983-01-17 1983-12-20 Suture rings for heart valves

Country Status (12)

Country Link
US (1) US4535483A (enExample)
EP (1) EP0119357B1 (enExample)
JP (1) JP2608869B2 (enExample)
AT (1) ATE27542T1 (enExample)
AU (1) AU557515B2 (enExample)
BR (1) BR8400148A (enExample)
CA (1) CA1211254A (enExample)
DE (1) DE3371862D1 (enExample)
DK (1) DK17584A (enExample)
ES (1) ES528890A0 (enExample)
IN (1) IN159219B (enExample)
NO (1) NO834641L (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7658705B2 (en) 2003-06-09 2010-02-09 Cardioenergetics, Inc. Actuation mechanisms for a heart actuation device
US7753837B2 (en) 2003-06-09 2010-07-13 The University Of Cincinnati Power system for a heart actuation device
US7850729B2 (en) 2002-07-18 2010-12-14 The University Of Cincinnati Deforming jacket for a heart actuation device

Families Citing this family (401)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5387247A (en) * 1983-10-25 1995-02-07 Sorin Biomedia S.P.A. Prosthetic device having a biocompatible carbon film thereon and a method of and apparatus for forming such device
US4759758A (en) * 1984-12-07 1988-07-26 Shlomo Gabbay Prosthetic heart valve
US4935030A (en) * 1985-06-17 1990-06-19 Medtronic, Inc. Mechanical heart valve prosthesis
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ES8601675A1 (es) 1985-11-01
US4535483A (en) 1985-08-20
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EP0119357A1 (en) 1984-09-26
JPS59137051A (ja) 1984-08-06
JP2608869B2 (ja) 1997-05-14
ATE27542T1 (de) 1987-06-15
DE3371862D1 (en) 1987-07-09
DK17584A (da) 1984-07-18
ES528890A0 (es) 1985-11-01
AU2310484A (en) 1984-07-19
CA1211254A (en) 1986-09-16
AU557515B2 (en) 1986-12-24

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